Bioequivalence and Bioavailability Forum • actual time for INPUT, nominal for the summarisation/report

actual time for INPUT, nominal for the summarisation/report [NCA / SHAM]

posted by ElMaestro – Denmark, 2012-04-17 13:25 (4811 d 20:09 ago) – Posting: # 8427
Views: 13,630

Hi Simon,

❝ That's how I've always analysed my data over the last 15+years. Slightly more tricky is when protocol requests 0-72 and some samples were not quantifiable at that timepoint, again if you have a value for Lz this will be extrapolated for you but for profiles with no Lz then WNL will do it's best to extrapolate, effectively using AUCall (or a fraction thereof) with all the inherent assumptions and approximations of that metric. On these occasions I would be tempted to consider reporting an AUC to last COMMON timepoint e.g. 48.

Sounds very interesting. Could you explain what this means in practice? Can you give an example?

Many thanks.

—
Pass or fail!
ElMaestro

Complete thread:

actual time AUC72 sciguy 2012-03-23 04:23 [NCA / SHAM]
- actual time AUC72 Dr_Dan 2012-03-23 10:25
  - actual times and AUC72 d_labes 2012-03-27 09:22
    - actual times and AUC72 sciguy 2012-04-02 20:44
      - WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 00:33
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 15:50
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 15:56
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-03 16:10
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) Helmut 2012-04-03 16:16
        
        WNL/PHX: pAUC72 (=hidden intra-/extrapolation) sciguy 2012-04-05 16:27
        
        pAUC72 or pAUC72+x Helmut 2012-04-05 18:25
        actual time for INPUT, nominal for the summarisation/report SDavis 2012-04-17 11:13
        
        actual time for INPUT, nominal for the summarisation/reportElMaestro 2012-04-17 11:25
        
        actual time for INPUT, nominal for the summarisation/report SDavis 2012-04-17 13:35
        
        Fishy? ElMaestro 2012-04-17 13:42
        
        ... don't think so SDavis 2012-04-17 14:09
        
        ... don't think so ElMaestro 2012-04-17 17:20
        
        AUCall and that all - Fishy? d_labes 2012-04-17 15:45
        
        Genau Detlew! SDavis 2012-04-17 16:29